Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01363388 | A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis | PHASE2 | COMPLETED | 67 | — | — | Sep 1, 2011 | Jan 1, 2016 | Mar 13, 2025 | 44 | Austria, Belgium +8 |
| NCT05984251 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants | PHASE1 | COMPLETED | 48 | — | — | Dec 21, 2009 | Apr 11, 2011 | Aug 9, 2023 | 1 | Switzerland |
Disease response is defined as BVAS percentage reduction from baseline of at least 50% plus no worsening in any body system component.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo plus a full dose of oral glucocorticoids for steps 1 and 2 of the study |
| CCX168 | EXPERIMENTAL | 30 mg Active study medication, plus either two-thirds reduced dose of oral glucocorticoids for step 1 of the study, or no oral glucocorticoids for step 2 of the study |
| Cohort 1 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 1 mg or placebo. During the second study period, participants will receive the same dose as during the first period but once daily (QD) for a period of 7 days continuously. |
| Cohort 2 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 3 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously. |
| Cohort 3 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 10 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously. |
| Cohort 4 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 30 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo twice daily (BID) for a period of 7 days continuously. |
| Cohort 5 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 100 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo BID for a period of 7 days continuously. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | BID for 84 days |
| CCX168 | DRUG | BID for 84 days |
Key Inclusion Criteria: * Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis or renal limited vasculitis * Male and postmenopausal or surgically sterile female subjects aged at least 18 years with new or relapsed AAV where treatment with cyclophosphamide or...